Simcere Pharmaceutical

Edit links
From Wikipedia, the free encyclopedia

This is an old revision of this page, as edited by Kku (talk | contribs) at 13:05, 11 October 2022 (link [gG]lioblastoma). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.

Simcere Pharmaceutical Group
Company typeListed, SEHK: 2096
IndustryPharmaceuticals
Headquarters
Nanjing, Jiangsu
,
China
RevenueRMB 5,000 million or USD 788.3 million (2021)
Number of employees
6,100+
Websitewww.simcere.com

Simcere Pharmaceutical Group or Simcere Pharmaceutical (Chinese: 先声药业, SEHK: 2096) is an innovation and R&D-driven pharmaceutical company with a mission of “providing today’s patients with medicines of the future.” It has established a National Key Laboratory of Translational Medicine and Innovative Drug Development. The company focuses on three therapeutic areas including oncology, central nervous system and autoimmune diseases with forward-looking layout of disease areas that may have significant clinical needs in the future. Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations[1] have made it a strategic cooperation partner with world leading innovative companies and research institutes. The company has been continuously recognized as one of the “Top Innovative Pharmaceutical Enterprises in China” and “Top 100 Pharmaceutical Manufacturing Enterprises of China”.


History

1995 - 2005: Manufacturer and supplier of branded generics

  • 1995 Company established[2]
  • 2001 Became a pharmaceutical company with independent R&D capability

2006 - 2015: Engaged in Generic and Innovative Drug Development

  • 2006 Endostar® (Recombinant human endostatin) launched
  • 2007 NYSE listing[3]

2015 - present: Innovative Drug Driven Company

  • 2018 Shanghai Innovation Center established
  • 2019 Boston Innovation Center established[4]
  • 2021 Enweida® (Envafolimab) launched


Products

The company strategically focuses on 3 Major Therapeutic Areas including oncology, central nervous system, autoimmune disease, with forward-looking layout of disease areas that may have significant clinical needs.

Simcere currently has a portfolio of dozens of market leading pharmaceutical products. Over 10 products are recommended in more than 40 clinical practice guidelines and pathways issued by government authorities or prestigious professional associations in China, and over 40 products are included in the Chinese national reimbursement drug list (NRDL).

Sanbexin®

Edaravone and Dexborneol Concentrated Solution for Injection, independently developed by Simcere with proprietary intellectual property right is indicated to alleviate neurological symptoms and dysfunction of daily activities caused by acute ischemic stroke. Sanbexin has been the only pharmaceutical for the treatment of stroke which has obtained the approval for sale since 2015 worldwide.

As a Chinese category 1 innovative drug, Sanbexin can improve the neurological function of patients with strokes by inhibiting the dual mechanisms of oxidative stress damage and inflammatory damage. Data from Phase III clinical study has been published in Stroke (journal). A total of approximately 1,200 acute ischemic stroke patients were included in a randomized, double-blind, positive controlled trial for head-to-head comparison of Sanbexin and edaravone monotherapy. Data shows that Sanbexin® has the efficacy advantage and is fairly safe.[5]

It has received national special support for "Major New Drug Creation Projects" by the Ministry of Science and Technology and been awarded as one of “China’s Milestone Medical Achievements During the 13th Five-Year Plan Period”. It is included in NRDL since 2020;

Iremod®

(Iremod® (iguratimod) tablet) independently developed by Simcere is the first iguratimod approved for sales in the world and the only iguratimod approved for sales in China.[6] It has been included in the NRDL since 2017 and is recommended as the primary therapy drug for the treatment of active rheumatoid arthritis by a number of clinical practice guidelines and pathways issued by the National Health Commission, Chinese Medical Association, Asia Pacific League of Associations for Rheumatology[7] and the Ministry of Health, Labour and Welfare of Japan.[8]

In March 2021, the results of the phase IV prospective real-world study on Iremod® were published online in The Lancet Regional Health-Western Pacific, a sub publication of The Lancet.[9] 1,759 patients were enrolled in this study, which made up for the lack of evidence of large-sample IGU in China and provided a new guiding basis for clinical safe and rational drug use.

Endostar®

Indicated for treatment of non-small cell lung cancer, Endostar® is the first proprietary anti-angiogenic targeted drug in China and the only endostatin approved for sale in worldwide.[10] Endostar inhibits tumor growth by its antiangiogenic effect, and has won the Second Prize of National Scientific and Technological Progress Award, and China Patent Gold Award.

Endostar® has been included in the NRDL since 2017 and is recommended as a first-line treatment for patients with advanced non-small-cell lung carcinoma (NSCLC) by a number of oncology clinical practice guidelines.

Envafolimab

Approved to the market in China since Nov 2021, Envafolimab (Enweida®)is the world's first single-domain PD-L1 antibody formulated for subcutaneous injection (SC) and the first immunotherapy approved in China indicated for MSI-H tumor regardless of tumor type, with the advantages of short administration time and good safety.[11]

It is indicated for adult patients with advanced solid tumors who have unresectable or metastatic microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR), including those patients with advanced colorectal cancer who have experienced disease progression after being treated with fluorouracil, oxaliplatin and irinotecan previously, as well as other patients with advanced solid tumors who have experienced disease progression after previous treatment and no satisfactory treatment alternatives.

On March 30, 2020, Simcere entered a tripartite cooperation agreement in relation to Envafolimab with 3D (Beijing) Medicines and Jiangsu Alphamab and obtained the exclusive right to promote Envafolimab for all oncology indications in mainland China.[12]

Other marketed products

Simcere collaborated with Bristol-Myers Squibb (BMS)[13] to develop and commercialize Orencia® (abatacept injection) in China since 2013. The drug is approved by NMPA in 2020 and became the first and only soluble CTLA4-Fc fusion protein approved for sale in China as treatment of rheumatoid arthritis.

Other branded products[14] of Simcere include Jepaso®: Nedaplatin for Injection, JIEBAILI®: Pemetrexed Disodium for Injection, Enlength®: Bortezomib for Injection, AIJIEWEI®: Tofacitinib Citrate Tablets, Softan®: rosuvastatin calcium tablets, Antine®: diclofenac sodium sustained release capsules/gel, ZAILIN®: amoxicillin granules/dispersible tablets/capsules, BIQI®: Diosmectite Powder[15] etc.


Pursuit of innovation

In the rapid transitioning towards an innovation driven company, Simcere has established four innovation centers globally, located in Nanjing, Shanghai, Beijing and Boston.

For the years of 2019, 2020, and 2021, Simcere's R&D costs accounted for 14.2%, 25.3%, and 28.3% respectively, of its total revenue for the same periods.[16]

As of March 2022, the company maintains a new drug R&D pipeline of nearly 60 innovative projects, with 19 innovative drug projects in the clinical stage.


Partnering and global alliances

Simcere collaborates extensively with domestic and foreign R&D partners to develop innovative medicines. It is striving to become a strategic "partner of choice" with world leading pharmaceutical companies and biotechnology companies, in an effort to bring more global life science breakthroughs to China.

Collaboration highlights:

G1 Therapeutics

Collaborate to introduce COSELATM (Trilaciclib), an innovative anti-tumor and myeloprotection therapy.[17]

Bristol-Myers Squibb

Co-development of Orencia® (Abatacept injection), the innovative drug in the field of autoimmune diseases.[18]

Kazia Therapeutics

Co-development of Paxalisib, which was granted Fast Track Designation for glioblastoma[19] by the US FDA in August 2020.[20]

Vivoryon Therapeutics

Collaborate to develop and commercialize Varoglutamstat, an orally administered small molecule inhibitor for Alzheimer's disease.[21]

Apexigen

Co-development of Suvencitug, a humanized monoclonal antibody directed against VEGF.[22]

Avilex Pharma

Collaboration on AVLX-144, an innovative drug for acute ischemic stroke (AIS).[23]

Aeromics

Co-development of a potent inhibitor of AQP4 water channels for the treatment of novel therapy with Nobel-winning mechanism to treat cerebral edema in China.[24]

JW Pharmaceutical

Collaboration on URC-102, a selective inhibitor of uric acid transporter (URAT-1) for gout in China.[25]

3D-Medicines & Alphamab Oncology

A strategic collaboration to develop and commercialize Enweida® (Envafolimab), the world’s first subcutaneously injected PD-L1 antibody.[26]

NeuronDawn

Collaborate to develop Sanbexin® (Edaravone and Dexborneol) sublingual tablet for stroke.[27]

Daiichi-Sankyo

Strategic partnership for the exclusive commercialization of Olmetec Plus® ( Olmesartan medoxomil, Hydrochlorothiazide) in China.[28]

Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Co-development of a novel antiviral drug targeting 3CL protease to treat COVID-19.[29]

Lynk Pharmaceuticals

Partnering to develop and commercialize a highly selective JAK1 inhibitor for the indications of rheumatoid arthritis and ankylosing spondylitis in China.[30]

References

  1. ^ Russell Flannery. China’s Simcere Pharmaceutical Advances At Home After Exit From NYSE. Forbes, September 13, 2021.
  2. ^ About Simcere/Milestones. Simcere Pharmaceutical Company website
  3. ^ China's Simcere jumps 11 pct in U.S. debut. REUTERS, April 20, 2007.
  4. ^ Massbio Member Directory/Simcere Innovation Inc. Massachusetts Biotechnology Council
  5. ^ Jie Xu, et al. 2021."Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke. "Stroke. 52:772–780
  6. ^ Simcere's Iremod Receives SFDA New Drug Approval. PRNewswire. August 25, 2011.
  7. ^ Lau, C. S. et al. 2015. "APLAR rheumatoid arthritis treatment recommendations." Int. J. Rheum. Dis. 18:685–713
  8. ^ Yutaka Kawahito et al. 2022. "Drug treatment algorithm and recommendations from the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis—secondary publication." Modern Rheumatology, roac017
  9. ^ Mu R et al. 2022. "Effectiveness and safety of iguratimod treatment in patients with active rheumatoid arthritis in Chinese: A nationwide, prospective real-world study." Lancet Reg Health West Pac, 10:100128
  10. ^ Li, K., Shi, M. & Qin, S. 2018. "Current Status and Study Progress of Recombinant Human Endostatin in Cancer Treatment." Oncol Ther, 6, 21–43
  11. ^ Li, J., Deng, Y., Zhang, W. et al. 2021. "Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors." J Hematol Oncol 14, 95
  12. ^ Alphamab inks oncology deal with Simcere and 3D Medicines. Biospectrumasia, March 31, 2020
  13. ^ [BMS-And-Simcere-To-Co-develop-Orencia-In-China-For-RA BMS And Simcere To Co-develop Orencia In China For RA. Srip Pharma Intelligence, July 4, 2013]
  14. ^ Simcere website/product
  15. ^ [Simcere's Diosmectite API Passes EU-GMP Inspection]
  16. ^ Simcere Pharmaceutical Group Limited ANNOUNCEMENT OF ANNUAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2021
  17. ^ Simcere and G1 Therapeutics Announce Exclusive License Agreement for Trilaciclib in Greater China.
  18. ^ Orencia® (Abatacept injection), the innovative drug in the field of rheumatology immunity co-developed by BMS and Simcere, is approved.
  19. ^ FDA Grants Fast Track Designation to Paxalisib for Patients with Glioblastoma. Cancer network, August 21, 2020.
  20. ^ Simcere Enters into Partnership with Kazia Therapeutics for Paxalisib in Greater China.
  21. ^ Simcere and Vivoryon Therapeutics Announce Strategic Regional Licensing Partnership for N3pE Amyloid-Targeting Medicines to Treat Alzheimer’s Disease in Greater China.
  22. ^ Apexigen Announces Initiation Of Clinical Trials By Its Partner, Simcere Pharmaceutical Group, APX003/BD0801 is being developed in China through an active partnership between Apexigen and Simcere.
  23. ^ Simcere and Avilex Pharma Announce Strategic Regional Licensing Partnership to Develop and Commercialize AVLX-144 for the Treatment of Acute Ischemic Stroke (AIS) in Greater China.
  24. ^ Aeromics and Simcere Announce Collaboration and License Agreement for AER-271 in Greater China.
  25. ^ Simcere and JW Pharmaceutical Announce Collaboration and License Agreement for Anti-Gout Drug Candidate URC-102 in China.
  26. ^ Envafolimab, The World’s First Subcutaneously Injected PD-L1 Antibody Approved by NMPA! Simcere Partners with Alphamab Oncology and 3DMed to Innovate Immunotherapy.
  27. ^ Sanbexin sublingual tablet is a new drug jointly developed by Simcere and NeuronDawn based on the clinical demands of AIS patients for more timely and sufficient treatment after stroke onset.
  28. ^ OLMETEC PLUS®：Olmesartan Medoxomil and Hydrochlorothiazide Tablets, developed and manufactured by Daiichi-Sankyo, its commercialization right on the Chinese market is entitled to Simcere.
  29. ^ Simcere and Shanghai Institute of Materia Medica Enter a Collaboration to Jointly Develop Next-Gen COVID-19 Oral Antiviral Treatments.
  30. ^ Simcere and Lynk Pharmaceuticals Announced Strategic Commercialization Partnership upon Novel JAK1 Inhibitor LNK01001.


Retrieved from "https://en.wikipedia.org/w/index.php?title=Simcere_Pharmaceutical&oldid=1115435325"